Kornimate/medical-research-clean huggingface dataset:
a phase 2 study using placenta derived decidual stromal cells for graft versus host disease

Conditions: Graft vs Host Disease

Summary: the purpose of this study is to evaluate the safety and efficacy using decidual stromal cell therapy for graft versus host disease after allogeneic hematopoietic stem cell transplantation. the hypothesis to be tested is that the cells are safe to infuse and that they have a positive clinical effect.

patients with gvhd grade 2-4, will receive decidual stromal cells at approximately 1x10\^6 cells/kg at one or more occasions at weekly intervals dependent on clinical response.

Eligibility criteria:
inclusion criteria: * acute graft versus host disease grade 2-4 or therapy resistant chronic graft versus host disease. * are on calcineurin inhibitor and high dose corticosteroids. exclusion criteria: * terminally ill patients

Keywords: stem cell transplantation decidual stromal cells
the use of triple fixed-dose combination in the treatment of arterial hypertension

Conditions: Arterial Hypertension

Summary: the use of triple fixed-dose combination in the treatment of arterial hypertension: opportunity for effective bp control with combined antihypertensive therapy. the main aim of this study to assess the antihypertensive effectiveness effect on the 24-hour bp profile, as well as tolerability of and compliance to the treatment with a triple fdc of amlodipine / indapamide / perindopril arginine in hypertensive patients in the real clinical practice. type of program: multicenter, observational, non-controlled, open-label program. investigators: cardiologists and outpatient (primary care) physicians (general practitioners). number of patients: 1,300 hypertensive patients.

it is multicenter, observational, non-controlled, open-label program. the baseline characteristics will be analyzed in all the patients who started the treatment (intention-to-treat \[itt\] population). in case of significant differences between two treatment groups, the baseline characteristics will be provided for both of them. changes in the sbp and dbp (with the corresponding confidence intervals) will be assessed in the patients who completed the program without major deviations from protocol (per-protocol population \[ppp\]). the analysis of parameters with normal distribution will be performed using the student's t-test for paired measurements; otherwise the non-parametric wilcoxon test will be used. the percentage of patients with normalized bp, as well as the percentage of patients who responded to treatment (with 95% confidence intervals), will be calculated. questionnaires: the score for each scale will be calculated as the sum of scores for questions constituting the scale. assessment of the aes will be carried out in all the patients who started the treatment (itt population).

Eligibility criteria:
inclusion criteria: * age 18 to 79 years * essential hypertension * patient's consent to participate in the program * doctor's decision to prescribe fdc of amlodipine / indapamide / perindopril arginine, according to the instruction for use, prior to the inclusion in the program. exclusion criteria: * symptomatic, or secondary arterial hypertension * office bp ≥ 180/110 mm hg on treatment (at v0 visit) * history of myocardial infarction, unstable angina, or cerebrovascular accident within the past 1 year * chf of class iii-iv nyha * type i diabetes or decompensated type 2 diabetes * diseases with severe organ dysfunction (hepatic failure, renal failure, etc.) * contraindications to or known intolerance of dihydropyridine calcium channel blockers (including amlodipine) and/or indapamide and/or ace inhibitors (including perindopril) and/or their fixed combination * inability to understand the nature of the program and/or to follow the doctor's recommendations, including ones for the bp self-monitoring.
pupil response in patients on opioids.

Conditions: Chronic Pain; Impaired Pupillary Reflex; Opioid-Related Disorders

Summary: evaluation of pupillary reflex in patients on high-dose opioids. clinical assessment of pain intensity, sedation score, and other side effects of opioids. measurements of the concentration of opioids and their active metabolites in blood.

pupil size reflects the balance between sympathetic and parasympathetic systems. pupil size and reaction are also influenced by drugs, where opioids result in miosis, an effect that is not considered to be influenced by opioid tolerance. however, cancer patients on high-dose opioids do not always present small pupil size. we want to perform a dynamic assessment of pupillary reflex in patients on high-dose opioids. in addition to pupil size measurements under standard room light conditions, two pupil size reflexes will by assessed: the pupillary light reflex when the pupil is exposed to light, and the reflex dilation during a standardized noxious stimulus. on the same time we will assess pain intensity, sedation score, and other side effects of opioids while measuring the concentration of opioids and their active metabolites in blood. in addition we will register all concomitant medication that also might influence pupil size and reaction. patients on more than 60 morphine equivalents pr day will be included.

Eligibility criteria:
inclusion criteria: * in-patients and out-patients at oslo university hospital with cancer pain who have use opioids (morphine, oxycodone, fentanyl or methadone or a combination of these drugs) at least for periods of 4 weeks, and use opioids corresponding to at least 60 mg oral morphine equivalents pr day exclusion criteria: * patients who have undergone eye-surgery that may influence pupillary reflexes * patients on local medication that may influence pupillary reflexes * patients with amyloidosis, multiple sclerosis, horner's syndrome, or ongoing migraine attack * patients with brain tumor
study of idursulfase-beta (gc1111) in hunter syndrome

Conditions: Mucopolysaccharidosis II

Summary: this study evaluates the efficacy and safety of three doses of gc1111 in patients with hunter syndrome. participants will be randomized to one of three doses of gc1111 or comparator.

this is a randomized, double-blind, active-controlled, dose-ranging study, where patient will receive one of the three doses of gc1111 (0.5 mg/kg, 1.0 mg/kg, and 1.5 mg/kg) or elaprase 0.5 mg/kg. approximately 20 patients will be administrated each study drug once every week as an iv infusion for 24 weeks. efficacy of gc1111 will be evaluated in six-minute walk test (6mwt), urine glycosaminoglycans(ugag), liver and spleen volume, percent predicted forced vital capacity(fvc), and cardiac size and function. also immunogenicity, pharmacokinetics(pk) and safety will be evaluated.

Eligibility criteria:
inclusion criteria: * male patients between 5 and 35 years of age * informed consent form signed * patients diagnosed with hunter syndrome * previously untreated with an enzyme replacement therapy exclusion criteria: * history of tracheostomy, bone marrow transplant, or cord blood transplant * treatment with another investigational product within 30 days prior to the start of study drug * known hypersensitivity of any of the ingredients of study drug * patient with severe hunter syndrome who cannot perform 6mwt * female patients
validation of an activities-of-daily-living framework at different light conditions

Conditions: Presbyopia; Near Vision; Reading; Daily Activities

Summary: primary objective of this study is the construction and validation of an experimental environment for the simulation of a variety of near- and intermediate-vision activities of daily living (adls) in different combinations of light temperature and light intensity.

among the objectives of the study is to validate a framework of adls that require near and intermediate vision and better reflect visual capacity, in a special experimental environment of 9 different combinations of light temperature and light intensity. the final list consists of the following ten basic adl tasks: 1. phone book search (pbs), 2. supermarket receipt (supre), 3. book reading (br), 4. cellular message (cm), 5. cellular entry search (ces), 6. reading computer screen (rcs), 7. drops bottle reading (dr), 8. subtitles reading (subre), 9. open door test (odt), and, 10. screwdriver test (st). the 9 light combinations are the following: 3000 k - 25 fc, 3000 k - 50 fc, 3000 k - 75 fc 4000 k - 25 fc, 4000 k - 50 fc, 4000 k - 75 fc 6000 k - 25 fc, 6000 k - 50 fc, 6000 k - 75 fc

Eligibility criteria:
inclusion criteria: * normophakic participants with a clear natural lens * age between 40 to 75 years old * unva: logmar 0.1, 0.4, or 0.7 exclusion criteria: * astigmatism \>1.00 diopters * glaucoma * intraocular pressure lowering medications * former incisional eye surgery * corneal or fundus disease * diabetes mellitus * autoimmune diseases * neurological, psychiatric or mental diseases

Keywords: activities of daily living presbyopia light temperature light intensity
ipsc repository of pediatric cardiovascular disease

Conditions: Congenital Heart Disease; Heart Diseases

Summary: obtain blood samples for generation and maintenance of induced pluripotent stem cells (ipscs) and genomic/dna sequencing for biomedical research that will improve the understanding and treatment of pediatric cardiovascular disease

human induced pluripotent stem cells (ipscs) are a type of pluripotent stem cell which can be generated from easily accessible patient cells, such as peripheral blood mononuclear cells and skin fibroblasts. as ipscs are epigenetically reprogrammed from somatic cells, they retain all genetic information of the affected patients, thus providing an ideal model for studying the contribution of genetic variation to pediatric cardiovascular disease. in addition, human ipscs can be differentiated into cardiomyocytes, endothelial cells, smooth muscle cells and cardiac fibroblasts, which are major affected cell types in the heart responsible for cardiovascular disease. therefore, patient-specific ipscs possess great promise in modeling pediatric cardiovascular disease, discovering novel drugs and prospective cell regeneration therapy. the dna from these patients will be analyzed for point mutations, rare sequence variations, single nucleotide polymorphisms in known cardiac development genes or for chromosomal copy number changes by using state of the art genetic approaches.

Eligibility criteria:
inclusion criteria: 1. the subjects must have the diagnosis of cardiovascular disease 2. the subject must have a syndrome associated with cardiovascular disease 3. the subject must be related to an individual in cohort 1 or 2 4. the subject is considered a control and does not fall into any of the other cohorts exclusion criteria: n/a

Keywords: ipsc
hypofractionated proton beam radiotherapy for hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: this phase ii study is to evaluate the effectiveness of hypofractionated proton beam therapy (pbt) for hcc patients in hepatitis b endemic area.

the primary endpoint is local progression free survival. the trial is a single arm phase ii trial with the historical arm. the expected 3-year local progression free survival for patient with hcc patients treated with proton beam therapy would be 80%. with a power of 80% and a type i error level of 10%, evaluable 40 patients are required to reject that the null hypothesis that true 3-year local progression free survival rate is ≤65%. considering the 10% unevaluable patients due to loss of follow up, a total 45 eligible patients for each arms will be enrolled.

Eligibility criteria:
inclusion criteria: * hcc diagnosed as (i) the presence of risk factors including hepatitis b or c virus and liver cirrhosis, a serum a-fetoprotein (afp) level greater than 200 iu/ml and a radiologically compatible feature with hcc in one or more ct/mri/angiograms, or (ii) the presence of risk factors including hepatitis b or c virus and liver cirrhosis, a serum a-fetoprotein (afp) level less than 200 iu/ml, and a radiologically compatible feature with hcc in two or more ct/mri/angiograms or (iii) histological confirmation * hcc patients who were not prospective suitable or refused for any other treatment, such as surgery or local ablation therapy, or recurrent or residual tumor after other treatments. * without evidence of extrahepatic metastasis * all target tumors must be encompassable within single irradiation field (15x15 cm maximum) * no previous treatment to target tumors by other forms of rt * liver function of child-pugh class a or b7 (child-pugh score of ≤7) * age of ≥18 years * performance status of 0 to 2 on the eastern cooperative oncology group (ecog) score * wbc count ≥ 2,000/mm3; hemoglobin level ≥ 7.5 g/dl; platelet count ≥ 25,000/mm3; and adequate hepatic function (total bilirubin ≤ 3.0 mg/dl; ast and alt \< 5.0× upper limit of normal; no ascites) * no serious comorbidities other than liver cirrhosis * written informed consent exclusion criteria: * evidence of extrahepatic metastasis * age \< 18 years * liver function of child-pugh class b8-9 and c (child-pugh score of \>7) * previous history of other forms of rt adjacent to target tumors * poor performance status of 3 to 4 on the eastern cooperative oncology group (ecog) score * multicentric hccs, except for those with the following two conditions: \*multinodular aggregating hcc that could be encompassed by single clinical target volume and within single irradiation field (15x15 cm maximum) \*lesions other than targeted tumor that were judged as controlled with prior surgery and/or local ablation therapy.
defining n-acetyl cysteine as a treatment for inhibiting prurogenic stimuli

Conditions: Pruritus; Skin Disorder

Summary: the objective of this double-blinded placebo-controlled cross-over study is to define the role of the over the counter agent, n-acetyl cysteine (nac), in mitigating the development of pruritus (skin itching). the study is designed to have all subjects treated with a seven-day regimen of both nac and placebo. nac will be prescribed at a dose of 1,500 mg twice daily for seven days. subjects will initially be randomly assigned (1:1) to either the nac or placebo arm of the study, before crossing over to the opposite arm after completing a minimum of 30-day washout period. the study will encompass a period of approximately 11 weeks (about 2 and a half months).


Eligibility criteria:
inclusion criteria: * males and females * all skin types (fitzpatrick types i - vi) * age 18 - 40 * able to comprehend procedures and risks exclusion criteria: * currently taking immunosuppressive or immunomodulating or psychotropic medications. this includes antihistamines and aspirin-like anti-inflammatory medications (nasids) for the past month. * history of peripheral neuropathy, charcot-marie-tooth, familial dysautonomia or heavy metal toxicity * history of gastrointestinal abnormalities (including irritable bowel syndrome) * history of inadequately controlled diabetes mellitus * history of abnormal scarring * history of skin infections within 6 weeks * history of skin disease (atopic dermatitis, psoriasis, xerosis) or "sensitive skin" * pregnancy or nursing * other serious health issues, including liver or kidney disease
efficacy and safety of asenapine with placebo and olanzapine (41022)(p05947)

Conditions: Schizophrenia

Summary: schizophrenia is a brain disease. the primary features of schizophrenia are characterized by positive symptoms (symptoms that should not be there, inability to think clearly, to distinguish reality from fantasy i.e., hearing voices) and negative symptoms (a reduction or absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and relate to others). other symptoms include reduced ability to recall and learn new information, difficulty with problem solving, or maintaining productive employment. the symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other. asenapine is an investigational drug that may help to correct the imbalance in dopamine and serotonin. this is a 6 week study to test the efficacy and safety of asenapine and a comparator agent (olanzapine) in the treatment of patients with schizophrenia. patients that complete this trial will have the option of continuing in an additional one year extension trial.


Eligibility criteria:
inclusion criteria: * currently suffering from an acute exacerbation of schizophrenia. exclusion criteria: * have an uncontrolled, unstable medical condition. have any other psychiatric disorder other than schizophrenia as a primary diagnosis.
an explanatory factors analysis of inflammatory bowel diseases(ibd's) management costs for adults patients treated by biotherapy and followed at nancy university hospital

Conditions: Inflammatory Bowel Diseases

Summary: the objective of this study is to analyze the factors influencing the medical and non-medical direct costs of patients treated with biotherapy during the last twelve months (infliximab or adalimumab), including biosimilars (infliximab biosimilars: inflectra ™ and remsima ™) for treating crohn's desease or ulcerative colitis


Eligibility criteria:
inclusion criteria: 1. patients consulted at the gastroenterology services of nancy university hospital during the period of inclusion 2. patients over 18 of age the day of consultation 3. patients treated at least one time by biotherapy during the last 12 months preceeding inclusion 4. patients with crohn's disease or ulcerative colitis. 5. patients accepting to respond to the questionnary exclusion criteria: * age under 18 years , the day of consultation * patient that not accept or unable to complete the retrospective questionnary

Keywords: chronic disease ulcerative colitis
epidural vs. systemic analgesia in the intensive care unit

Conditions: Patients With Acute Pain Admitted to the Intensive Care Unit

Summary: many patients admitted to the general intensive care unit suffer from pain, whether acute or chronic. those patients include post-operative patients, multi trauma, acute pancreatitis and patients with multiple rib fractures. most patients in the intensive care unit, whether intubated and ventilated or not, are treated with systemic analgesic drugs, usually given intravenously, enterally, or trans dermally (fentanyl patches). continuous epidural anesthesia has been shown in several studies to have an advantage over systemic analgesia in specific conditions, such as pancreatitis, multiple rib fractures and upper abdominal surgeries. some of its benefits include improved gastrointestinal motility (reduction of ileus rates), decreased thromboembolic events (dvt) and better quality of pain control. in intubated and ventilated patients, continuous epidural anesthesia may reduce the amount of required systemic sedation. reducing the amount of sedation may contribute to a decrease in delirium rates, shortening the time to extubation and reducing other adverse effects associated with high requirements of sedation drugs (such as a decrease in blood pressure). most of the studies comparing systemic analgesia to epidural analgesia examined a population of patients hospitalized in the surgical ward, post breast, abdominal or orthopedic surgeries of the pelvis and lower extremities, or due to other conditions such as pancreatitis or multiple rib fractures. there are almost no studies that have examined the effectiveness of epidural analgesia in patients admitted to the intensive care unit, including sedated and ventilated patients, compared with systemic analgesia. from 2011 until today, our intensive care unit has admitted about 300 patients who were treated with continuous epidural analgesia. in this study we would like to compare them to another group of patients (about 300 patients as well), who were admitted to the unit for similar etiologies (post-operative, multi- trauma, pancreatitis, etc.), and to observe differences between the groups. we would like to examine differences in mortality within 28 days, as well as differences in morbidity, such as the level of analgesia and delirium rates between groups.


Eligibility criteria:
inclusion criteria:patients aged 18-99, admitted to the general intensive care unit from january 2011 to june 2021 (inclusive), due to a medical condition that may expose them to significant pain during hospitalization: chest, abdominal, pelvic or lower extremity surgery, pancreatitis, multiple rib fractures, trauma including chest, abdominal, pelvic, or lower limb trauma, and treated with epidural or systemic anesthesia during their stay in the unit. - exclusion criteria:patients not admitted for the above reasons. -

Keywords: acute pain, epidural analgesia, intensive care unit
diagnostic value of c-reactive protein and white blood cell counts for early detection of inflammatory complications after open resection of colorectal cancer

Conditions: Given Indication for Open Resection of Colorectal Cancer

Summary: although widely used, there is a lack of evidence concerning diagnostic value of c-reactive protein (crp) and white blood cell counts (wbc) in the postoperative course. the aim of this study was to evaluate the diagnostic accuracy of crp and wbc for postoperative inflammatory complications after open resection of colorectal cancer.


Eligibility criteria:
inclusion criteria: * all patients with resection of colorectal cancer exclusion criteria: * lack of measurement of c-reactive protein * lack of measurement of white blood cell counts